Label: COMFORTOX TETRACAINE- tetracaine hcl cream

  • NDC Code(s): 54723-997-01
  • Packager: Sambria Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 3, 2023

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  • ​Active Ingredients

    Tetracaine HCL     2.0% w/w

  • ​Purpose

    External Analgesic

  • ​Uses

    For temporary relief of pain and itching due to minor skin irritation

  • WARNINGS

    ​For external use only

    Avoid contact with eyes

  • DO NOT USE

    ​Do not use​ in large quantities, particularly over raw surfaces or blistered areas

  • STOP USE

    ​Stop use and ask a doctor if​

    • Condition worsens, or if symptoms persist for more then 7 days or clear up and occur again within a few days.  Discontinue use.

  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children​

    • If product is swallowed, get medical help or contact a Poison Control Center right away.

  • ​Directions

    For adults and children two-years or older: Apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age: consult a physician.

  • ​Inactive Ingredients

    Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine

  • ​Other Information

    Protect this product from excessive heat and direct sun.

  • ​Questions or Comments?

    FDA Registered: NDC No. 54723-997-01

    800-693-9067

  • PRINCIPAL DISPLAY PANEL

    packet

  • INGREDIENTS AND APPEARANCE
    COMFORTOX TETRACAINE 
    tetracaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-997
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV) TETRACAINE HYDROCHLORIDE20 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CHONDROITIN SULFATE SODIUM (BOVINE) (UNII: 8QTV3DTT8W)  
    EMU OIL (UNII: 344821WD61)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54723-997-011500 mg in 1 PACKET; Type 0: Not a Combination Product09/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/14/2016
    Labeler - Sambria Pharmaceuticals, Inc. (078676259)
    Establishment
    NameAddressID/FEIBusiness Operations
    A.I.G. Technologies, Inc.086365223manufacture(54723-997)
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